Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans

Sponsor

VA Sierra Nevada Health Care System (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT05789706

Collaborator

(none)

Enrollment

Location

Arms

23.2

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a novel smartphone-based medication adherence platform accompanied by directed pharmacist intervention can improve A1c control and medication compliance in non-insulin dependent diabetics.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabete Type 2	Behavioral: Dayamed Arthur a novel intelligent medication adherence platform	N/A

Detailed Description

This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm (See Figure 1). Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.

Primary outcomes will be the change from pre-intervention baseline in hemoblobin A1c (HgA1c) between the Dayamed Arthur platform and standard of care.

Secondary outcomes will include change in MAS, the change in RMA from week 1 of intervention arm to week 12, comparison of historical MPR and PDC with patient's RMA at week 1 of intervention arm, and correlation of change in RMA and MAS score during intervention arm. Furthermore, we will measure sustained change in MAS in the patient population who begin study in the intervention arm and are subsequently transitioned to standard of care. We will also collect information patient usability/acceptability and provider satisfaction with the Dayamed Arthur platform.

Exploratory outcomes will include potential reduction in healthcare resource utilization based on avoidance of therapy escalation in patients with improved compliance, as well as psychosocial factors associated with improved adherence

Reduction of HgbA1c by 0.5% from pre-intervention baseline for individuals on the DayaMed intervention compared to standard of care

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm. Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm. Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans: a Pragmatic, Point-of-care, Implementation Effectiveness Pilot Study

Actual Study Start Date :

Mar 24, 2021

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Patients will have Dayamed Arthur a novel intelligent medication adherence platform installed on their smartphone and configured with their pharmacy data providing accurate prompts and reminders to patients to take medications as directed In addition to the prompts patient all auditable information will be relayed to their PACT CPS through a provider dashboard allowing for timely and directed clinical intervention. Dayamed Arthur will provide automated alerts to the patients care team in specific scenarios.	Behavioral: Dayamed Arthur a novel intelligent medication adherence platform Novel smart phone adherence application configured with subject pharmacy data providing accurate reminders of when to take medications and providing auditable user feed back to clinical care teams for patient response directed provider intervention.
No Intervention: Standard of Care Arm Study subjects will be counseled on medication adherence and strategies to remember how to take their medications correctly. Study subjects will then be followed as clinically indicated by their clinical care team.

Arm

Intervention/Treatment

Experimental: Intervention Arm

Patients will have Dayamed Arthur a novel intelligent medication adherence platform installed on their smartphone and configured with their pharmacy data providing accurate prompts and reminders to patients to take medications as directed In addition to the prompts patient all auditable information will be relayed to their PACT CPS through a provider dashboard allowing for timely and directed clinical intervention. Dayamed Arthur will provide automated alerts to the patients care team in specific scenarios.

Behavioral: Dayamed Arthur a novel intelligent medication adherence platform

Novel smart phone adherence application configured with subject pharmacy data providing accurate reminders of when to take medications and providing auditable user feed back to clinical care teams for patient response directed provider intervention.

No Intervention: Standard of Care Arm

Study subjects will be counseled on medication adherence and strategies to remember how to take their medications correctly. Study subjects will then be followed as clinically indicated by their clinical care team.

Outcome Measures

Primary Outcome Measures

Change from pre-intervention baseline in hemoblobin A1c [3 months]
The change from pre-intervention baseline in hemoblobin A1c (HgA1c) to 3 months in the intervention arm compared to change from baseline to 3 months in the standard of care arm

Secondary Outcome Measures

Change in Medication Adherence Score from baseline [3 months]
change from baseline to 3 months in medication adherence score in the intervention arm compared to change from baseline to 3 months in medication adherence score in the standard of care arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Assigned primary care provider at VA Sierra Nevada Healthcare System (VASNHCS)
Diagnosis of type 2 diabetes
Own a smart phone/tablet
HgbA1c drawn at or within 30 days of study enrollment.
Uncontrolled A1c defined as an A1c >9 in the following order of preference
Last 3 A1cs >9% in the last 2 year
Last 2 A1cs >9% in the last 2 years
Last A1c >9% in the last 2 years
2-year average A1c >9%

Exclusion Criteria:

Actively on insulin therapy
Unable to install DayaMed application onto their phone/tablet
Unable to load medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Sierra Nevada Health Care System	Reno	Nevada	United States	89502

Sponsors and Collaborators

VA Sierra Nevada Health Care System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amneet Rai, Associate Chief of Pharmacy - Health Outcomes and Analytics, VA Sierra Nevada Health Care System

ClinicalTrials.gov Identifier:

NCT05789706

Other Study ID Numbers:

1655381

First Posted:

Mar 29, 2023

Last Update Posted:

Mar 29, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 29, 2023